[Federal Register Volume 60, Number 129 (Thursday, July 6, 1995)]
[Proposed Rules]
[Pages 35266-35272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15703]




[[Page 35265]]

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Part II





Department of Health and Human Services





_______________________________________________________________________



Public Health Service



_______________________________________________________________________



42 CFR Part 52b



National Institutes of Health Construction Grants; Proposed Rule

  Federal Register / Vol. 60, No. 129 / Thursday, July 6, 1995 / 
Proposed Rules  

[[Page 35266]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

42 CFR Part 52b

RIN 0905-AD49


National Institutes of Health Construction Grants

AGENCY: Public Health Service, Department of Health and Human Services 
(HHS).

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The National Institutes of Health (NIH) proposes to revise its 
regulations governing construction grants for the purpose of making 
them applicable to all NIH financial assistance programs with 
construction grant authority, including programs transferred to NIH by 
the ADAMHA Reorganization Act and two new programs authorized by the 
National Institutes of Health Revitalization Act of 1993. The 
regulations are also being revised for the purpose of correcting Public 
Health Service (PHS) Act section numbers referenced in the regulations 
and adding new administrative and technical requirements for the 
awarding of these grants and cost recovery procedures for the recovery 
of grant funds for facilities no longer used for biomedical research 
purposes.

DATES: Comments on these proposed regulations must be received on or 
before September 5, 1995 in order to ensure that NIH will be able to 
consider the comments in preparing the final rule.

ADDRESSES: Comments should be sent to: Mr. Jerry E. Moore, NIH 
Regulatory Affairs Officer, National Institutes of Health, Building 31, 
Room 1B25, 31 Center DR MSC 2075, 9000 Rockville Pike, Bethesda, 
Maryland 20892-2340.

FOR FURTHER INFORMATION CONTACT: Mr. Jerry E. Moore, NIH Regulatory 
Affairs Officer, at the address above, or telephone (301) 496-4606 
(this is not a toll-free number).

SUPPLEMENTARY INFORMATION: Under the Public Health Service (PHS) Act, 
as amended (42 U.S.C. 201 et seq.), construction or modernization grant 
authority exists in sections 413(b)(6)(B) and 414(b) for the National 
Cancer Institute (construction grants); sections 421(b)(2)(B) and 
422(c)(3) for the National Heart, Lung, and Blood Institute 
(construction grants); section 441(a) for the National Institute of 
Arthritis and Musculoskeletal and Skin Diseases (modernization grants); 
section 455 for the National Eye Institute (construction grants); 
section 464C(a) for the National Institute on Deafness and Other 
Communication Disorders (modernization grants); section 464P(b)(3) for 
the National Institute on Drug Abuse (construction grants); section 
481A(a) for the Director of NIH, acting through the Director of the 
National Center for Research Resources (construction and modernization 
grants); section 481B(a) for the Director of NIH (construction grants); 
and section 2354(a)(5)(B) for NIH AIDS research programs (construction 
grants).
    NIH proposes to revise the existing regulations at 42 CFR part 52b 
(National Cancer Institute Construction Grants) to make them applicable 
to all NIH financial assistance programs with construction or 
modernization grant authority. Part 52b would be retitled and the 
authority citation would be amended to add the additional construction 
and modernization grant authorities. Sections 52b.2 and 52.3 would be 
revised in their entirety. Section 52b.4 would be amended by revising 
paragraph (d) to reference Executive Order 12372 and adding a new 
paragraph (e) regarding the protection of Historical Properties listed 
on National and State Historical Registers. Section 52b.5 would be 
revised in its entirety. Sections 52b.6, 52b.7, 52b.8, 52b.9, 52b.10, 
and 52b.11 would be revised and moved to Secs. 52b.14, 52b.6, 52b.10, 
52b.11, 52b.13 and 52b.12, respectively. The PHS Act sections 
referenced in the regulations would be corrected. Three new sections 
would be added to part 52b. A new Sec. 52b.7 would be added specifying 
facility usage requirements; a new Sec. 52b.8 would be added concerning 
NIH monitoring of the usage of biomedical research facilities 
constructed with Federal funds; and a new Sec. 52b.9 would be added 
concerning procedures to recover Federal funds for facilities that 
cease to be used for biomedical research purposes. Section 52b.10 would 
add new requirements relating to the recording of notice of Federal 
interest and the purchasing of insurance. Section 52b.12 concerning 
minimal requirements of construction and equipment would be revised to 
incorporate by reference additional published standards relating to 
facility design, construction, and operation standards. In accordance 
with section 552(a) of the Freedom of Information Act (5 U.S.C. 552) 
and implementing regulations, 1 CFR part 51, NIH will request the 
approval of the Director of the Federal Register prior to incorporating 
by reference any new published material in the final rule.
    Section 52b.14 would be revised to cite additional HHS regulations 
and policies that apply to part 52b. These regulations do not apply to 
minor alterations and renovations that are included in applications for 
research project grants. Minor alterations and renovations are covered 
under the regulations at 42 CFR part 52. These regulations also do not 
cover alterations and renovations under NIH center grants. These 
alterations and renovations are covered under the regulations at 42 CFR 
part 52a. The purpose of this notice is to invite public comment on 
these proposed changes.
    PHS strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the nonuse of all tobacco products, and 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities that receive Federal funds in which education, 
library, day care, health care, and early childhood development 
services are provided to children.
    The following statements are provided for the information of the 
public.

Regulatory Impact Statement

    Executive Order 12866 of September 30, 1993, Regulatory Planning 
and Review, requires us to prepare an analysis for any rule that meets 
one of the E. O. 12866 criteria for a significant regulatory action; 
that is, that may--
    Have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities;
    Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    Materially alter the budgetary impact of grants, user fees, or loan 
programs or the rights and obligations of recipients thereof; or
    Raise novel legal or policy issues arising out of legal mandates, 
the President's priorities, or the principles set forth in E.O. 12866.
    In addition, the Department prepares a regulatory flexibility 
analysis, in accordance with the Regulatory Flexibility Act of 1980 (5 
U.S.C. chapter 6), if the rule is expected to have a significant impact 
on a substantial number of small entities.
    For the reasons outlined below, we do not believe this NPRM is 
economically significant nor do we believe that it will have a 
significant impact on a substantial number of small entities. In 
addition, this NPRM is not inconsistent with the actions of any other 
agency. 

[[Page 35267]]

    This NPRM would merely update internal policies and procedures of 
the Federal government which are used by the NIH to administer 
construction grants awarded under the authority set forth in section 
413(b)(6)(B), 414(b), 421(b)(2)(B), 422(c)(3), 441(a), 455, 464C(a), 
464P(b)(3), 481A(a), 481B(a) and 2354(a)(5)(B) of the PHS Act. These 
grants do not have significant economic or policy impact on a broad 
cross-section of the public. Furthermore, the revised regulations would 
only affect the limited number of public or private nonprofit agencies 
of institutions which are interested in participating in the 
construction grant program. No agency or institution is required to 
participate in the program. The revised regulations include no 
standards or requirements which would burden small entities.
    For these same reasons, the Secretary certifies this NPRM will not 
have a significant economic impact on a substantial number of small 
entities, and that a Regulatory Flexibility Analysis, as defined under 
the Regulatory Flexibility Act of 1980, is not required.

Paperwork Reduction Act

    This proposed rule contains information collection requirements 
which are subject to Office of Management and Budget (OMB) approval 
under the Paperwork Reduction Act of 1980 (44 U.S.C. chapter 35). The 
title, description, and respondent description of the information 
collection requirements in this proposed rule are presented below with 
an estimated annual burden. The information collection requirements 
contained in these regulations have been submitted to OMB for review. 
Other organizations and individuals desiring to submit comments on the 
information collection requirements should send their comments to (1) 
Dr. Charles MacKay, Project Clearance Officer, National Institutes of 
Health, Building 31, Room 5B33, 9000 Rockville Pike, Bethesda, Maryland 
20892-2174, and (2) the Office of Information and Regulatory Affairs, 
OMB, New Executive Office Building, Room 10235, 725 17th St., N.W., 
Washington, D.C. 20503. Attention: Desk Officer for the National 
Institutes of Health, Department of Health and Human Services. After 
OMB approval is obtained, the OMB control number will be published in 
the Federal Register.
    Title: NIH Construction Grants.
    Description: The information collections will be used by NIH to 
evaluate grant applications, oversee the transfer of the title of a 
constructed facility, and monitor the use being made of a constructed 
facility.
    Respondent Description: Public or private nonprofit agencies or 
institutions.

                               Estimated Annual Reporting and Recordkeeping Burden                              
----------------------------------------------------------------------------------------------------------------
                                       Annual number      Annual      Average burden                            
                                      of respondents     frequency     per response       Annual burden hours   
----------------------------------------------------------------------------------------------------------------
Reporting:                                                                                                      
    Sec.  52b.9(b)..................               1               1             .50                         .50
    Sec.  52b.10(f).................              15               1               1                       15   
    Sec.  52b.10(g).................              30              12               1              360   
    Sec.  52b.11(b).................             100               1               1                  * (100)   
                                                                                     ---------------------------
        Subtotal....................                                                                      375.5 
                                                                                     ---------------------------
Recordkeeping:                                                                                                  
    Sec.  52b.10(g).................              30             260               1             7800   
                                                                                     ---------------------------
        Total.......................                                                                     8175.5 
----------------------------------------------------------------------------------------------------------------
* This burden is approved under OMB Approval Number 0937-0189                                                   
 Based on an average of 30 active grants in the construction phase.                                     

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbered programs 
affected by these proposed regulations are:

93.392--Cancer Construction
93.131--Shared Research Facilities for Heart, Lung, and Blood 
Diseases
93.846--Arthritis, Musculoskeletal and Skin Diseases Research

List of Subjects in Part 52b

    AIDS research facilities construction; Basic biomedical research 
laboratory facilities construction; Cancer research facilities 
construction; Clinical biomedical and behavioral research facilities 
construction; Grants--construction; Incorporation by reference; Primate 
research facilities construction; Research facilities construction for 
AIDS; Research facilities construction for arthritis, musculoskeletal 
and skin diseases; Research facilities construction for heart, lung, 
and blood diseases; Vision research facilities construction.

    Dated: December 28, 1994.
Philip R. Lee,
Assistant Secretary for Health.

    Approved: June 19, 1995.
Donna E. Shalala,
Secretary.

    For reasons set out in the preamble, it is proposed to revise part 
52b of title 42 of the Code of Federal Regulations to read as set forth 
below.

PART 52b--NATIONAL INSTITUTES OF HEALTH CONSTRUCTION GRANTS

Sec.
52b.1  To what programs do these regulations apply?
52b.2  Definitions.
52b.3  Who is eligible to apply?
52b.4  How to apply.
52b.5  How will NIH evaluate applications?
52b.6.  What is the rate of Federal financial participation?
52b.7  How is the grantee obligated to use the facility?
52b.8  How will NIH monitor the use of facilities constructed with 
Federal funds?
52b.9  What is the right of the United States to recover Federal 
funds when facilities are not used for research or are transferred?
52b.10  What are the terms and conditions of awards?
52b.11  What are the requirements for acquisition and modernization 
of existing facilities?
52b.12  What are the minimum requirements for construction and 
equipment?
52b.13  Additional conditions.
52b.14  Other HHS regulations and policies that apply.


[[Page 35268]]

    Authority: 42 U.S.C. 216, 285a-2, 285a-3, 285b-3, 285b-4, 285d-
6, 285i, 285m-3, 285o-4, 287a-2, 287a-3, 300cc-41.


Sec. 52b.1  To what programs do these regulations apply?

    The provisions of this part apply to grants authorized by: section 
413(b)(6)(B) of the Act for construction or renovation of basic cancer 
research laboratory facilities, including clinical facilities; section 
414(b) of the Act for the construction of centers for basic and 
clinical research into, training in, and demonstration of advanced 
diagnostic, prevention, control, and treatment methods for cancer; 
section 421(b)(2)(B) of the Act for the construction or renovation of 
heart, blood vessel, lung, and blood disease and blood resource 
laboratories, research, training, and other facilities as the Director 
determines necessary; section 422(c)(3) of the Act for the construction 
of centers for basic and clinical research into, training in, and 
demonstration of, the management of blood resources and advanced 
diagnostic, prevention, and treatment methods for heart, blood vessel, 
lung, or blood diseases; section 441(a) of the Act for the 
modernization of existing buildings to serve as centers for basic and 
clinical research into the cause, diagnosis, early detection, 
prevention, control, and treatment of and rehabilitation from arthritis 
and musculoskeletal diseases, including research into implantable 
biomaterials and biomechanical and other orthopedic procedures; section 
455 of the Act for the construction of vision research facilities; 
section 464C(a) for the modernization of existing buildings to serve as 
multipurpose centers for basic and clinical research into the cause, 
diagnosis, early detection, prevention, control and treatment of 
disorders of hearing and other communication processes including 
research into rehabilitative aids, implantable biomaterials, auditory 
speech processors, speech production devices, and other otolaryngologic 
procedures; section 464P(b)(3) of the Act for the construction of 
pharmacotherapeutic research centers, laboratories, and other necessary 
facilities and equipment to conduct research on the development and use 
of medications to treat drug addiction; section 481A(a) of the Act for 
the expansion, remodeling or alteration of existing research 
facilities, or the construction of new research facilities; section 
481B(a) of the Act for the construction or renovation of regional 
centers for research on primates; and section 2354(a)(5)(B) of the Act 
for the construction of facilities for acquired immunodeficiency 
syndrome (AIDS) research. The provisions of this part do not apply to 
minor alteration and renovation that is included in the application for 
a research project grant. This type of alteration and renovation is 
covered under the regulations at 42 CFR part 52.
Sec. 52b.2  Definitions.

    As used in this part:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    Construction means the construction of new buildings or the 
modernization of, or the completion of shell space in, existing 
buildings (including the installation of fixed equipment), but 
excluding the cost of land acquisition and off-site improvements.
    Construction grant means funds awarded for construction in 
accordance with the applicable provisions of the Act and with this 
part.
    Director means the director of an NIH national research institute, 
center, or other component of NIH, authorized to award grants for 
construction under the applicable provisions of the Act, and any 
official to whom the authority involved is delegated.
    Federal share with respect to any construction project means the 
proportion, expressed as a percentage, of the cost of the project to be 
paid by a grant award under the Act.
    HHS, DHHS, and Department mean the Department of Health and Human 
Services.
    Institute means any national research institute, center, or other 
agency of the National Institutes of Health as set forth in or 
established by the Secretary under section 401 of the Act.
    Modernization means the alteration, renovation, remodeling, 
improvement, expansion, and repair of existing buildings and the 
provision of equipment necessary to make the building suitable for use 
for the purposes of the particular program.
    NIH means the National Institutes of Health and its organizational 
components that award grants.
    Nonprofit as applied to any agency or institution means an agency 
or institution which is a corporation or an association, no part of the 
net earnings of which inures or may lawfully inure to the benefit of 
any private shareholder or individual.
    Project means the particular construction activity which is 
supported by a grant under this part.
    Secretary means the Secretary of Health and Human Services and any 
official to whom the authority involved may be delegated.


Sec. 52b.3  Who is eligible to apply?

    In order to be eligible for a construction grant under this part, 
the applicant must:
    (a) Be a public or private nonprofit agency or institution;
    (b) Be located in a State, the District of Columbia, Puerto Rico, 
the Virgin Islands, the Canal Zone, Guam, American Samoa, or the 
successor States of the Trust Territory of the Pacific Islands (the 
Federated States of Micronesia, the Republic of the Marshall Islands, 
and the Republic of Palau); and
    (c) Meet any additional eligibility criteria specified in the 
applicable provisions of the Act.


Sec. 52b.4  How to apply.

    Applications for construction grants under this part shall be made 
in such form and at such times as the Secretary may specify.


Sec. 52b.5  How will NIH evaluate applications?

    (a) In evaluating and approving applications for construction 
grants under this part, the Director shall take into account, among 
other pertinent factors, the following:
    (1) The priority score,
    (2) The relevance of the project for which construction is proposed 
to the objectives and priorities of the particular statutory program 
under the Act,
    (3) The scientific merit of the research program activities which 
will be carried out in the proposed facility,
    (4) The scientific or professional standing or reputation of the 
applicant and of its existing or proposed officers and research staff,
    (5) The availability, by affiliation, or other association, of 
other scientific or health personnel and facilities to the extent 
necessary to carry out effectively the program proposed for the 
facility, including the adequacy of an acceptable biohazard control and 
containment program when warranted,
    (6) The need for the facility and its total effects on similar or 
related facilities in the locale, and the need to accomplish 
appropriate geographic distribution of similar facilities, and
    (7) The financial need of the applicant.
    (b) The priority score of the application shall be based, among 
other pertinent factors, on the following criteria:
    (1) The scientific merit of the total program and its component 
parts to be carried out in the facility,
    (2) The administrative and leadership capabilities of the 
applicant's officers and staff, 

[[Page 35269]]

    (3) The organization of the applicant's research program and its 
relationship with the overall institutional settings,
    (4) The anticipated effect of the project on other relevant 
research programs and facilities in the geographic area, and nation-
wide,
    (5) The need for the project or additional space, and
    (6) The project cost and design.


Sec. 52b.6  What is the rate of Federal financial participation?

    (a) Unless otherwise specified in statute, the rate of Federal 
participation in a construction project supported by a grant under this 
part shall not be more than 50 percent of the necessary allowable costs 
of construction as determined by the Director, except that when the 
Director finds good cause for waiving this limitation, the amount of 
the construction grant may be more than 50 percent of the necessary 
allowable costs of construction.
    (b) Subject to paragraph (a) of this section, the Director shall 
set the actual rate of Federal financial participation in the necessary 
allowable costs of construction taking into consideration the most 
effective use of available Federal funds to further the purposes of the 
applicable provisions of the Act.


Sec. 52b.7  How is the grantee obligated to use the facility?

    (a) The grantee shall use the facility (or that portion of the 
facility supported by a grant under this part) for its originally 
authorized purpose so long as needed for that purpose, unless that 
grantee obtains advance written approval from the Director to use the 
facility for another purpose. Use for other purposes shall be limited 
to, in order of priority:
    (1) Projects or programs supported by other Federal grants or 
assistance agreements,
    (2) Activities not supported by other Federal grants or assistance 
agreements, but whose purposes are consistent with those of the 
legislation under which the original grant was made.
    (b) The Director, in determining whether to approve an alternative 
use of the facility, shall take into consideration the extent to which:
    (1) the facility will be devoted by the grantee or other owner to a 
use described in paragraph (a)(1) or (2) of this section; or
    (2) there are reasonable assurances that for the remainder of the 
useful life of the facility, alternative facilities not previously used 
for NIH supported research will be utilized for this purpose and are 
substantially equivalent in nature and extent for these purposes.
    (c) Sale, transfer, or change in use; general. Approval may be 
requested from the Director to transfer title to a third party eligible 
under Sec. 52b.3 for continued use for authorized purposes in 
accordance with paragraphs (a) and (b) of this section. If approval is 
permissible under the Act or other Federal statute and is granted, the 
terms of the transfer shall provide that the transferee shall assume 
all the rights and obligations of the transferor set forth in 45 CFR 
part 74, subpart O, or other terms of the grant.


Sec. 52b.8  How will NIH monitor the use of facilities constructed with 
Federal funds?

    NIH may monitor the use of each facility constructed with funds 
awarded under this part to ensure its continued use for the original 
authorized research purpose, by means of requesting periodic facility 
use certifications or reports, site visits, and other appropriate 
means.


Sec. 52b.9  What is the right of the United States to recover Federal 
funds when facilities are not used for research or are transferred?

    (a) If, during its useful life, a facility supported by a 
construction grant under this part ceases to be used for the particular 
biomedical research or training purposes for which it was constructed 
(or alternate use authorized under Sec. 52b.7(a)), or the grantee sells 
or decides to sell or transfer title to an entity ineligible for a 
grant under Sec. 52b.3, the grantee shall request disposition 
instructions from NIH. Those instructions will provide for one of the 
following alternatives:
    (1) The facility may be sold and the grantee or transferee shall 
pay to the United States an amount computed by multiplying the Federal 
share of the facility times the proceeds from the sale (after deducting 
the actual and reasonable selling and fix-up expenses, if any, from the 
sales proceeds), plus interest, if any, as may be allowed by law. 
Proper sales procedures shall be used that provide for competition to 
the extent practicable and result in the highest possible return.
    (2) The grantee may retain title and shall pay to the United States 
an amount computed by multiplying the market value of the facility by 
the Federal share of the facility.
    (3) The grantee shall transfer the title to either the United 
States or to an eligible non-Federal party approved by the Director. 
The grantee shall be entitled to be paid an amount computed by 
multiplying the market value of the facility by the non-Federal share 
of the facility.
    (b) The transferor of a facility which is sold or transferred, or 
the owner of a facility the use of which has changed, as described in 
paragraph (a) of this section, shall provide the Director written 
notice of the sale, transfer, or change not later than 30 days from the 
date on which the sale, transfer, or change occurs.
    (c) The Secretary may waive the recovery rights of the United 
States set forth in paragraph (a) of this section with respect to a 
facility if the Secretary determines that there is good cause for 
waiving the rights with respect to the particular facility. In 
determining whether there is good cause, the Secretary shall take into 
consideration the extent to which (and the grantee or transferee 
provides reasonable assurances that):
    (1) the facility will be utilized for the remainder of its useful 
life, in order of priority:
    (i) For other health related activities consistent with the 
purposes of one or more of the activities of the awarding Institute 
authorized under title IV of the Act,
    (ii) To provide training or instruction in the health fields for 
health professionals or health related information programs for the 
public, or
    (iii) Other health related purposes consistent with one or more 
purposes authorized under the Act; or,
    (2) facilities of substantially comparable value or utility will be 
utilized for the remainder of the facility's useful life to carry out 
the biomedical research or training purpose for which the grant was 
awarded. Alternative facilities (and the grantee) shall be subject to 
the same use obligation and the other requirements imposed on the 
grantee by this part.
    (d) The right of recovery of the United States set forth in 
paragraph (a) of this section shall not, prior to judgment, constitute 
a lien on any facility with respect to which funds have been paid under 
this part.
    (e) Any amount recovered under this section will be paid to the 
awarding institute for disposition as required by law.


Sec. 52b.10  What are the terms and conditions of awards?

    In addition to any other requirement imposed by law or determined 
by the Director to be reasonably necessary with respect to any 
particular grant to fulfill the purposes of the grant, each 
construction grant shall be subject to the terms and conditions, and 
the grantee shall provide the assurances, required by this section, 
supported by such documentation as the Director may 

[[Page 35270]]
reasonably require. The Director may, by general policy or for good 
cause shown by an applicant, approve exceptions to these terms and 
conditions or assurances where the Director finds that the exceptions 
are consistent with the applicable provision of the Act and the 
purposes of the particular program:
    (a) Title. That the applicant has a fee simple or such other estate 
or interest in the site, including necessary easements and rights-of-
way sufficient to assure for the estimated useful life of the facility, 
as determined by the Director, undisturbed use and possession for the 
purpose of the construction and operation of the facility.
    (b) Plans and specifications. That approval by the Director of the 
final working drawings, specifications, and cost estimate shall be 
obtained before the project is advertised or placed on the market for 
bidding. The approval shall include a determination by the Director 
that the final plans and specifications conform to the minimum 
standards of construction and equipment as set forth in Sec. 52b.12 of 
this part.
    (c) Relocation assistance. That in the case of a public applicant 
with an approved project which involves the displacement of persons or 
businesses on or after January 4, 1971, the applicant will comply with 
the provisions of the Uniform Relocation Assistance and Real Property 
Acquisition Policies Act of 1970 (42 U.S.C. 4601 et seq.) and the 
applicable regulations issued under that Act (45 CFR part 15).
    (d) Approval of changes in estimated cost. That the applicant will 
not enter into any construction contract or contracts for the project 
or a part thereof, the cost of which is in excess of the estimated cost 
approved in the terms of an award for that portion of the work covered 
by the plans and specifications, without the prior approval of the 
Director.
    (e) Completion responsibility. That the applicant will construct 
the project, or cause it to be constructed, to final completion in 
accordance with the grant application, the terms of award, and the 
approved plans and specifications.
    (f) Construction inspection. Prior to the start of construction, 
the grantee shall submit an approved copy of the construction schedule 
(critical path method) to the Director.
    (g) Construction management. That the applicant will provide and 
maintain competent and adequate construction management services for 
inspection at the construction site to ensure that the completed work 
conforms with the approved plans and specifications. Construction 
management services will also include daily construction logs and 
monthly status reports which will be maintained at the job site and 
shall be submitted to the Director at the time and in the form and 
manner as the Director may prescribe.
    (h) Non-Federal share. That sufficient funds are available to meet 
the non-Federal share of the costs of constructing the facility.
    (i) Funds for operation. That sufficient funds will be available 
when construction is completed for effective use of the facility for 
the purposes for which it is being constructed.
    (j) Inspection. That the Director and the Director's 
representatives shall have access at all reasonable times to all work 
during any stage of construction and the contractor shall provide 
proper facilities for this access and inspection.
    (k) Accessibility to handicapped. That the facility shall be 
designed to comply with the Federal Accessibility Standards (41 CFR 
subpart 101-19.6), as modified by other standards prescribed by the 
Director or the Administrator of General Services. The applicant will 
be responsible for conducting inspections to insure compliance with 
these specifications by the contractor.
    (l) Notice of Federal interest. The grantee shall record a Notice 
of Federal Interest in the appropriate official records of the 
jurisdiction in which the property is located.
    (m) Title insurance. The grantee shall purchase a title insurance 
policy unless a legal opinion has been provided which certifies that 
the grantee institution has fee simple title to the site free and clear 
of all liens, easements, rights-of-way, and any other adverse interests 
which would encumber the project. A waiver to this requirement may be 
obtained if the grantee is adequately self-insured against the risks 
involved.
    (n) Physical destruction insurance. At the time construction is 
completed or at the time of beneficial occupancy, whichever comes 
first, the grantee shall purchase an insurance policy which insures the 
facility at the full appraised value of the property using State 
certified appraisers. The insurance policy must protect the property 
from total or partial physical destruction and must be maintained 
throughout the period of Federal interest. A waiver to this requirement 
may be obtained if the grantee is adequately self-insured against the 
risks involved.


Sec. 52b.11  What are the requirements for acquisition and 
modernization of existing facilities?

    In addition to the other requirements of this part, the following 
requirements are applicable to the acquisition and modernization of 
existing facilities.
    (a) Minimum standards of construction and equipment. A 
determination by the Director that the facility conforms (or upon 
completion of any necessary construction will conform) to the minimum 
standards of construction and equipment as set forth in Sec. 52b.12 of 
this part, shall be obtained before entering into a final or 
unconditional contract for the acquisition and/or remodeling of 
facilities. Where the Director finds that exceptions to or 
modifications of construction or equipment would be consistent with the 
purposes of the applicable section of the Act under which the 
acquisition is supported, the Director may authorize the exceptions or 
modifications.
    (b) Estimated cost of acquisition and remodeling: Suitability of 
facility. Each application for a project involving the acquisition of 
existing facilities shall include in the detailed estimates of the 
costs of the project, the cost of acquiring these facilities, and any 
cost of remodeling, renovating or altering the facilities to serve the 
purposes for which they are acquired. The application shall demonstrate 
to the satisfaction of the Director that the architectural, mechanical, 
electrical, plumbing, structural, and other pertinent features of the 
facility, as modified by any proposed expansion, remodeling, 
renovation, or alteration, will be clearly suitable for the purposes of 
the applicable sections of the Act.
    (c) Bona fide sale. Grant awards for the acquisition of existing 
facilities shall be subject to the condition that the acquisition 
constitutes a bona fide sale involving an actual cost to the applicant 
and will result in additional or improved facilities for purposes of 
the applicable provisions of the Act.
    (d) Facility which has previously received a Federal grant. No 
grant for the acquisition or modernization of a facility which has 
previously received a Federal grant for construction, acquisition, or 
equipment shall serve either to reduce or restrict the liability of the 
applicant or any other transferor or transferee from any obligation of 
accountability imposed by the Federal Government by reason of the prior 
grant. 

[[Page 35271]]



Sec. 52b.12  What are the minimum requirements for construction and 
equipment?

    In addition to being subject to other regulations and policies 
referred to in Sec. 52b.14, the standards set forth in this section 
have been determined by the Director to constitute minimum requirements 
for construction and equipment, including the expansion, remodeling, 
renovation, or alteration of existing buildings, and these standards as 
may be amended, or any revisions or successors of these standards, 
shall apply to all projects for which Federal assistance is requested 
under the applicable sections of the Act. In accordance with 5 U.S.C. 
552(a)(1), the publications to which reference is made in this section, 
unless otherwise indicated, are hereby incorporated by reference and 
made a part of the regulations in this part. The Director may for good 
cause shown approve plans and specifications which contain deviations 
from the requirements prescribed, if the Director is satisfied that the 
purposes of the requirements have been fulfilled. In addition to these 
requirements, each project shall meet the requirements of State and/or 
local codes and ordinances relating to construction.
    (a) Mandatory design and construction standards. The facility 
design and construction shall comply with the following standards:
    (1) ``Guidelines for Construction and Equipment for Hospital and 
Medical Facilities'' (current edition). American Institute of 
Architects, 1735 New York Avenue, NW., Washington, DC 20006.
    (2) ``Laboratories Chapter, American Society of Heating, 
Refrigerating and Air Conditioning Engineers (ASHRAE) Handbook'' 
(current edition). ASHRAE, 1791 Tullie Circle, NE., Atlanta, Georgia 
30329.
    (3) ``Uniform Federal Accessibility Standards,'' Federal Standard 
795 (current edition). General Services Administration.
    (4) Seismic safety for federally assisted construction--Earthquake 
Hazards Reduction Act of 1977, as amended (42 U.S.C. 7701 et seq.) and 
Executive Order 12699, ``Seismic Safety of Federal and Federally 
Assisted or Regulated New Building Construction,'' dated January 5, 
1990. The Executive Order requires that, effective January 5, 1993, new 
federally assisted or regulated buildings are to be designed and 
constructed using appropriate seismic standards. The latest edition of 
the model codes listed below provide a level of seismic safety that is 
considered appropriate for implementing E.O. 12699 and are applicable 
to all federally assisted construction, depending on geographical 
location. State, county, or local jurisdictional building ordinances 
adopting and enforcing these model codes in their entirety, without 
significant revisions in the direction of less seismic safety, are also 
acceptable.
    (i) 1991 International Conference of Building Officials (ICBO) 
Uniform Building Code;
    (ii) 1992 Supplement to the Building Officials and Code 
Administrators International (BOCA) National Building Code;
    (iii) 1992 Amendments to the Southern Building Code Congress (SBCC) 
Standard Building Code; and
    (iv) ``Recommended Lateral Force Requirements and Commentary'' of 
the Seismology Committee, Structural Engineers Association of 
California.
    (5) ``Life Safety Code'' (current edition). National Fire 
Protection Association (NFPA) Publication 101. NFPA, 1 Batterymarch 
Park, Quincy, Massachusetts 02269.
    (6) ``Standards on Fire Protection for Laboratories Using 
Chemicals'' (current edition). National Fire Protection Association 
(NFPA) Publication No. 45. NFPA, 1 Batterymarch Park, Quincy, 
Massachusetts 02269.
    (7) ``Prudent Practices for Handling Hazardous Chemicals in 
Laboratories.'' (National Academy Press (1981)) National Research 
Council, 2001 Wisconsin Avenue, NW., Washington, DC 20007.
    (8) ``National Sanitation Foundation Standard No. 49 for Class II 
(Laminar Flow) Biohazard Cabinetry'' (current edition). National 
Sanitation Foundation (NSF), 3475 Plymouth Road, P.O. Box 1468, Ann 
Arbor, Michigan 48106.
    (9) ``Industrial Ventilation'' (current edition). American 
Conference of Governmental Industrial Hygienists, 6500 Glenwood Avenue, 
Cincinnati, Ohio 45211.
    (10) ``Health Care Facilities Handbook'' (current edition). 
National Fire Protection Association, 1 Batterymarch Park, Quincy, 
Massachusetts 02269.
    (11) ``Standards for Nonflammable Medical Gas Systems'' (current 
edition). National Fire Protection Association (NFPA) Publication No. 
99. NFPA, 1 Batterymarch Park, Quincy, Massachusetts 02269.
    (12) ``National Electric Code'' (current edition). National Fire 
Protection Association (NFPA) Publication No. 70. NFPA, 1 Batterymarch 
Park, Quincy, Massachusetts 02269.
    (13) ``Guide for the Care and Use of Laboratory Animals'' (current 
edition). DHHS Publication No. (NIH) 85-23.
    (14) ``Laboratory Ventilation'' standards, ANSI/AIHA (current 
edition).
    (15) ``Design Policy and Guidelines'' (current edition). Division 
of Engineering Services, National Institutes of Health.
    (b) [Reserved]


Sec. 52b.13  Additional conditions.

    The Director may with respect to any grant award impose additional 
conditions consistent with the regulations of this part prior to or at 
the time of any award when in the Director's judgment the conditions 
are necessary to assure or protect advancement of the approved project, 
the purposes of the applicable provisions of the Act, or the 
conservation of grant funds.


Sec. 52b.14  Other Federal regulations and policies that apply.

    Several other Federal regulations and policies apply to grants 
under this part. These include, but are not necessarily limited to:
    (a) Regulations.

9 CFR part 3--Animal welfare; standards.
29 CFR part 1910--Occupational safety and health standards; 
Sec. 1910.1450--Occupational exposure to hazardous chemicals in 
laboratories.
36 CFR part 1190--Minimum guidelines and requirements for accessible 
design.
42 CFR part 50, subpart A--Responsibility of PHS awardee and 
applicant institutions for dealing with and reporting possible 
misconduct in science.
42 CFR part 50, subpart D--Public Health Service grant appeals 
procedure.
45 CFR part 16--Procedures of the Departmental Grant Appeals Board.
45 CFR part 46--Protection of human subjects.
45 CFR part 74--Administration of grants.
45 CFR part 75--Informal grant appeals procedures.
45 CFR part 76--Governmentwide debarment and suspension 
(nonprocurement) and governmentwide requirements for drug-free 
workplace (grants).
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services--
effectuation of title VI of the Civil Rights Act of 1964.
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title.
45 CFR part 84--Nondiscrimination on the basis of handicap in 
programs and activities receiving Federal financial assistance.
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal 
financial assistance.
45 CFR part 91--Nondiscrimination on the basis of age in HHS 
programs or activities receiving Federal financial assistance.
45 CFR part 93--New restrictions on lobbying.

[[Page 35272]]

45 CFR part 92--Uniform administrative requirements for grants and 
cooperative agreements to State and local governments.

    (b) Policies.
    (1) 51 FR 16958 (May 7, 1986)--NIH Guidelines for Research 
Involving Recombinant DNA Molecules. [Note: this policy is subject to 
changes, and interested persons should contact the Office of 
Recombinant DNA Activities, NIH, Suite 323, 6006 Executive Blvd., MSC 
7052, BETHESDA, MD 20892-7052 (301-496-9838; not a toll-free number) to 
obtain the current version and any amendments. There may be a charge 
for materials provided.]
    (2) 59 FR 14508 (March 28, 1994)--NIH Guidelines on the Inclusion 
of Women and Minorities as Subjects in Clinical Research. [Note: this 
policy is subject to changes, and interested persons should contact the 
Office of Research on Women's Health, NIH, Room 201, Building 1, MSC 
0161, BETHESDA, MD 20892-0161 (301-402-1770; not a toll-free number) to 
obtain the current version and any amendments. There may be a charge 
for materials provided.]
    (3) ``Public Health Service Policy on Humane Care and Use of 
Laboratory Animals,'' Office for Protection from Research Risks, NIH 
(Revised September 1986). [Note: this policy is subject to changes, and 
interested persons should contact the Office for Protection from 
Research Risks, NIH, Suite 3B01, 6100 Executive Blvd., MSC 7507, 
ROCKVILLE, MD 20852-7507 (301-496-7005; not a toll-free number) to 
obtain the current version and any amendments. There may be a charge 
for materials provided.]
    (4) ``PHS Grants Policy Statement,'' DHHS Publication No. (OASH) 
94-50,000 (Rev.) April 1, 1994. [Note: this policy is subject to 
changes, and interested persons should contact the Grants Policy 
Branch, OASH, Room 17A45, Parklawn Building, 5600 Fishers Lane, 
Rockville, MD 20857 (301-443-1874; not a toll-free number) to obtain 
the current version and any amendments. There may be a charge for 
materials provided.]
    (5)``Biosafety in Microbiological and Biomedical Laboratories.'' 
Centers for Disease Control and Prevention (CDCP). DHHS Publication No. 
(CDC) 88-8395. [Note: this policy is subject to changes, and interested 
persons should contact the Division of Safety, Occupational Safety and 
Health Branch, NIH, Room 3K04, 13 South Drive, MSC 5760, BETHESDA, MD 
20892-5760 (301-496-2960; not a toll-free number) to obtain the current 
version and any amendments. There may be a charge for materials 
provided.]
    (6) ``NIH Guidelines for the Laboratory Use of Chemical 
Carcinogens.'' DHHS Publication No. (NIH) 81-2385. [Note: this policy 
is subject to changes, and interested persons should contact the 
Division of Safety, Occupational Safety and Health Branch, NIH, Room 
3K04, 13 South Drive, MSC 5760, BETHESDA, MD 20892-5760 (301-496-2960; 
not a toll-free number) to obtain the current version and any 
amendments. There may be a charge for materials provided.]
    (7) ``Guide for the Care and Use of Laboratory Animals.'' DHHS 
Publication No. (NIH) 85-23. Office for Protection from Research Risks, 
NIH (Revised September 1986). [Note: this policy is subject to changes, 
and interested persons should contact the Office for Protection from 
Research Risks, NIH, Suite 3B01, 6100 Executive Blvd., MSC 7507, 
ROCKVILLE, MD 20852-7507 (301-496-7005; not a toll-free number) to 
obtain the current version and any amendments. There may be a charge 
for materials provided.]

[FR Doc. 95-15703 Filed 7-5-95; 8:45 am]
BILLING CODE 4140-01-P